New FDA Guidances for December 2016

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. – Final Guidance 30 Dec 2016
Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 30 Dec 2016
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 28 Dec 2016
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry – Draft Guidance 28 Dec 2016
Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry – Draft Guidance 28 Dec 2016
Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry – Draft Guidance 28 Dec 2016
Botanical Drug Development: Guidance for Industry – Final Guidance 28 Dec 2016
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product – Final Guidance 28 Dec 2016
Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff – Final Guidance 28 Dec 2016
ANDA Submissions — Refuse-to-Receive Standards Rev.2 -Final Guidance 21 Dec 2016
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers – Final Guidance 14 Dec 2016
Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 14 Dec 2016
Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Guidance for Industry – Final Guidance 12 Dec 2016
Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 12 Dec 2016
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry – Final Guidance 08 Dec 2016
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format – Final Guidance 02 Dec 2016
Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry – Draft Guidance 01 Dec 2016
Upcoming Meetings (* = New)
* March 15, 2017: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement
* 2017 Advisory Committee Tentative Meetings
* new entry
Last updated: 06 January 2017
This entry was posted in Cato Research, Clinical Trials, FDA, Regulatory Strategy, Regulatory Submissions, Uncategorized and tagged , , . Bookmark the permalink.

Comments are closed.